# K032065: Medline Band Bags and Equipment Covers

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Sep 22, 2003 after 81 days
- Product code: MMP (Cover, Barrier, Protective)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K050322: Microtek Equipment Drapes (2005), 9 descendants of its own
- K112782: Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories (2011), 2 descendants of its own
- K081476: Surgical Concept Designs Positionor Surgical Drape (2008), 1 descendant of its own
- K052395: Sterile Equipment Covers (2005), 1 descendant of its own
- K141438: Whitney Medical Solutions Eshield (2014), 0 descendants of its own

## Recalls of this device
- May 18, 2023 · Class II · Z-2154-2023: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- May 15, 2023 · Class II · Z-2290-2023: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

## Indications for use
Medline Band Bags and Equipment Covers are intended to be used to cover medical equipment in order to maintain the sterile field and as an aid in the clean up of equipment after surgery. These covers are not intended to be used as patient drapes and have no patient contact.

Source page: https://510kreport.com/device/K032065
Methodology: https://510kreport.com/methodology